Spacers for use in brachytherapy, radiotherapy, and other medical therapy

ABSTRACT

Spacers for use in brachytherapy, radiotherapy, and other medical therapy, which can be used to improve a patient&#39;s outcome, assist in treating difficult cases and/or combine multiple modalities that are currently performed separately into a single procedure. In accordance with an embodiment, a spacer is formed of an encapsulating material in a generally cylindrical or elongated shape. One or more regions are formed within the spacer for receiving and retaining therapeutic loads, such as radiation sources and/or pharmaceutical therapeutic loads, and/or any other substances that a physician might select to treat a patient, such as drug liquids, powder or particles (e.g., microparticles or nanoparticles), with the particles or powders combined with binders, such as polyacrylamide, that are selected to retain and gradually disperse the powder or particles at a desired rate. Such regions can be formed at various locations within the spacer, and can have various shapes depending on the particular design and intended usage, including, for example, bores, end cavities, wells, ports, slots and/or pockets. The outer surface of the encapsulating material can optionally include one or more fins, ribs or other physical protuberances or features that improve the fixity of the spacer when implanted within a patient&#39;s body. When implanted into the body, the spacer helps provide proper placement and spacing such as symmetrical and/or asymmetrical placement and spacing of the radiation sources and/or pharmaceutical therapeutic loads.

CLAIM OF PRIORITY

This application claims the benefit of priority to U.S. ProvisionalPatent Application titled “SPACERS FOR USE IN BRACHYTHERAPY,RADIOTHERAPY, AND OTHER MEDICAL THERAPY”, Application No. 61/327,540,filed Apr. 23, 2010; which application is herein incorporated byreference.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to copending U.S. patent application Ser.No. 11/489,895 (published as U.S. Publication No. US2007/0021642),titled “Devices to Resist Migration and Rotation of Implants Used inBrachytherapy and Other Radiation Therapy”; and U.S. patent applicationSer. No. 12/361,285 (published as U.S. Publication No. US2009/0216063),titled “Bio-absorbable Brachytherapy Strands,” both of whichapplications are incorporated by reference herein.

FIELD OF INVENTION

Embodiments of the present invention are generally related tobrachytherapy, and are particularly related to therapeutic spacers, foruse in implantation and placement of radiation source or pharmaceuticaltherapeutic loads.

BACKGROUND

Diseases such as cancer are a leading cause of hospitalizations. In theUnited States alone, 250,000 men are diagnosed with prostate cancerevery year. For the majority of these cases, the disease is localized,and the available treatments include surgery, external beamradiotherapy, and brachytherapy. Approximately 36% of patients choosebrachytherapy, which includes the use of radioactive sources orradiation sources placed close to, or within, areas of diseased tissue,and which is particularly beneficial in treating certain types of tumor,such as prostrate cancers.

Temporary brachytherapy is the placement of the radiation source for ashort duration, typically several minutes or hours, before beingwithdrawn. Permanent brachytherapy, also known as seed implantation, isthe implanting and positioning small radioactive seeds in the tumor,positioned or spaced apart from one another using a spacer, and thenpermanently leaving the seeds within the patient, or until they aregradually absorbed by the body. The use of seeds and similar sourcesallows a relatively high dose of radiation to be precisely delivered tothe treatment site, while minimizing radiation to surrounding healthytissue. Brachytherapy can be used by itself, or in combination withother therapies, such as surgery or chemotherapy.

Brachytherapy is commonly used in the treatment of prostate cancer,sometimes together with systemic chemotherapy. Currently brachytherapyspacers (elements separating brachytherapy seeds) are smooth,cylindrical segments of bioabsorbable suture material. These spacerswere originally made from catgut (ovine or bovine). Currently thesespacers are made from bioabsorbable polymers. The spacers functionsimply as spacing elements to maintain the relative spacing between thetreatment seeds, but have little other effect. This is the general areathat embodiments of the invention are intended to address.

SUMMARY

Described herein are embodiments of spacers for use in brachytherapy,radiotherapy, and other medical therapy, which can be used to improve apatient's outcome, assist in treating difficult cases and/or combinemultiple modalities that are currently performed separately into asingle procedure. In accordance with an embodiment, a spacer is formedof an encapsulating material in a generally cylindrical or elongatedshape. One or more regions are formed within the spacer for receivingand retaining therapeutic loads, such as radiation sources and/orpharmaceutical therapeutic loads, and/or any other substances that aphysician might select to treat a patient, such as drug liquids, powderor particles (e.g., microparticles or nanoparticles), with the particlesor powders combined with binders, such as polyacrylamide, that areselected to retain and gradually disperse the powder or particles at adesired rate. The therapeutic agents can also be sprayed onto the spaceror mixed or incorporated into the material of the spacer. Thetherapeutic agents can, in embodiments, elute from the spacer. Suchregions can be formed at various locations within the spacer, and canhave various shapes depending on the particular design and intendedusage, including, for example, bores, end cavities, wells, ports, slotsand/or pockets. The outer surface of the encapsulating material canoptionally include one or more fins, ribs or other physicalprotuberances or features that improve the fixity of the spacer whenimplanted within a patient's body.

Embodiments of the spacers help to provide proper placement and spacingof any therapeutic agent that is placed in the slots, pockets, grooves,bores, cavities and other recesses provided in the spacer. Also enabledin symmetrical and asymmetrical placement of therapeutic agents in thespacer by providing some selected ones of the slots, pockets, grooves,recesses and the like with certain therapeutic agents. Embodiments ofthe spacer can be used alone or in combination with brachytherapy seedsin order to deliver therapy loads such as radiation and/or drug therapyloads. When used to provide a distance between brachytherapy radiationseeds, one or more embodiments of the spacers can be placed betweenseeds. Embodiments of the spacers can be formed in a long strand andthen embodiments of individual spacers can be cut or otherwise formed tolength form the strand in accordance with a treatment prescription plan.When implanted into the body, the spacer helps provide proper placementand spacing of the radiation brachytherapy seeds or sources.

Therapeutics can include, by way of example only, chemotherapy drug,antibiotic drug, anti-inflammatory drug and Botox type drug. Besidesdrugs, the wells can be filled with radiation media, contrast media andany other treatment substance including substances for cell marking andphotodynamic therapy. Unlike the use of traditional therapies that areeither performed separately and/or systemically, embodiments of thepresent invention allow for combining multiple modalities into a singleprocedure, such as the precise placement of a chemotherapy drug withinthe same brachytherapy procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a three-dimensional partial cutaway illustration of anspacer in accordance with an embodiment.

FIG. 2 (FIGS. 2A-2D) shows an example of a spacer in accordance with aparticular embodiment.

FIG. 3 (FIGS. 3A-3C) shows an example of a spacer in accordance with analternative embodiment.

FIG. 4 (FIGS. 4A-4C) shows an example of a spacer in accordance with analternative embodiment.

FIG. 5 (FIGS. 5A-5D) shows an illustration of the installation and useof a plurality of spacers in accordance with an alternative embodiment.

DETAILED DESCRIPTION

As described above, cancers such as prostate cancer are frequentlytreated using brachytherapy, of which permanent brachytherapy or seedimplantation has shown substantial success. The use of seeds and similarsources allows a relatively high dose of radiation to be preciselydelivered to the treatment site, while minimizing radiation tosurrounding healthy tissue. However, it can be difficult to treat somecancers with conventional brachytherapy spacers and seeds alone.

Described herein are embodiments of spacers for use in brachytherapy,radiotherapy, and other medical therapy, which can be used to improve apatient's outcome, assist in treating difficult cases and/or combinemultiple modalities that are currently performed separately into asingle procedure. In accordance with an embodiment, a spacer is formedof an encapsulating material in a generally cylindrical or elongatedshape. One or more regions are formed within the spacer for receivingand retaining therapeutic loads, such as radiation sources and/orpharmaceutical therapeutic loads, and/or any other substances that aphysician might select to treat a patient, such as drug liquids, powderor particles (e.g., microparticles or nanoparticles), with the particlesor powders combined with binders, such as polyacrylamide, that areselected to retain and gradually disperse and elute the powder orparticles or therapeutic agent at a desired rate. Such regions can beformed at various locations within the spacer, and can have variousshapes depending on the particular design and intended usage, including,for example, bores, end cavities, wells, ports, slots and/or pockets.The outer surface of the encapsulating material can optionally includeone or more fins, ribs or other physical protuberances or features thatimprove the fixity of the spacer when implanted within a patient's body.When implanted into the body, the spacer helps provide proper placementand spacing of radiation seeds and/or sources.

In accordance with an embodiment, a combination of seeds and spacers canreduce or eliminate the need for stranding seeds, and give moreflexibility in the filing of custom treatment plans. Embodiments of thecurrent invention provide the ability to anchor the spacer between theseeds.

In accordance with an embodiments, the spacer can be supplied to acustomer in a string or rod form (to be subsequently cut to length, inwhich instance the string can also have cut point indicators to assistin the cutting process), in which the device can be made, for example,with a core of hydrophobic or length stable bioabsorbable polymer withthe outer surface or encapsulating layer being made of a hydrophilicbioabsorbable polymer. Accordingly, the device will maintain its cutlength, while the outer porous surface can absorb edema to maintain aposition in the needle trace for both the spacer and the seed. Inaccordance with an embodiment the core can be made of a variety ofbiocompatible materials that are either bioabsorbable ornon-bioabsorbable, such as polydioxanone or PDS. Alternatively, theouter hydrophilic and/or bio-absorbable material becomes absorbed in thebody and in doing so becomes more securely located in the tissue. As thehydrophilic material becomes absorbed, the remaining hydrophilicmaterial has an irregular surface which is retained in the tissue. Stillalternatively, the core hydrophobic material can have an irregular outersurface that is coated with a bio-absorbable and/or hydrophilic materialthat has a smoother outer surface offering less resistance for initialinjection into the tissue. As the bio-absorbable material is absorbedinto the tissue, the irregular outer surface of the core engages thetissue and holds the spacer in place. Individual spacers can also besupplied to the customer. In accordance with an embodiment, to use thespacer or similar device for drug elution, the spacer is immersed into aliquid containing the drug, dehydrated and loaded it into abrachytherapy needle or similar applicator for implantation, and whereinonce implanted into the patient's body, the spacer is rehydrated tocause the drug to elute.

Therapeutics can include chemotherapy drug, antibiotic drug,anti-inflammatory drug and Botox type drug. Besides drugs, the wells canbe filled with radiation media, contrast media and any other treatmentsubstance including substances for cell marking and photodynamictherapy.

FIG. 1 shows a three-dimensional partial cutaway illustration of aspacer in accordance with an embodiment. As shown in FIG. 1, inaccordance with an embodiment, the spacer 100 is formed of anencapsulating material 102, which forms the overall shape and appearanceof the spacer, and which provides supports for any therapeutic loadstherein. As indicated herein, the encapsulating material can be ahydrophilic material that can be absorbed into the tissue, whichabsorption helps retain the spacer in place in tissue. The encapsulatingmaterial can cover a core material which is hydrophobic in order tomaintain the dimensions of the spacer, for example the length dimension.In accordance with an embodiment, the spacer can have a generallycylindrical or elongated shape about its longitudinal axis 104. Thespacer can also have a spacer length 106, which is variable depending onthe particular design and intended usage. The interior 108 of the spacercan be formed of, or can contain, either an amount of a similarencapsulating material, a different material, one or more voids, or acombination of material and voids, so that the spacer as a whole hasdifferent regions of material and/or voids.

In accordance with an embodiment, one or more regions are formed withinthe spacer for receiving therapeutic loads. These regions can be thesame or different from the voids described above. Such regions can besimilarly variable depending on the particular design and intendedusage, and can include, for example, a center longitudinal bore 110, oneor more end cavities 112, and/or slots or pockets 114.

As used herein, the terms “slots” and “pockets” are used to refer todetents, recesses, cavities or other forms of region which have asimilar purpose in receiving therapeutic loads (such as radiationsources or pharmaceutical therapeutic loads, indicated by way of examplein FIG. 1 as therapeutic loads 120 and 122 respectively), with thedistinction being that pockets are typically considered closed-ended,while slots are typically considered open-ended or otherwise appear asholes extending transversely through the spacer from a first side to anopposite side.

FIG. 1 illustrates an embodiment of a spacer having recesses of the slottype, wherein the slots extend transversely through the spacer from itsfirst dorsal side to its opposite dorsal side. If the slot includes abarrier along its length, then it is more appropriately considered apocket. Slots and pockets can be separated within the spacer by aslot-separation distance 116, which is similarly variable depending onthe particular design and intended usage.

In accordance with an embodiment, the outer surface of the spacer canoptionally include one or more fins, ribs or other physicalprotuberances or features 118. The protuberances can be providedlongitudinally around the spacer and/or provided circumferentiallyaround the spacer. Some examples of the type of physical protuberancesor features that can be used are described in copending U.S. patentapplication Ser. No. 11/489,895 (published as U.S. Publication No.2007/0021642), which application is incorporated by reference herein.Such features improve the fixity of the spacer when placed within thepatient's body, since they act to physically reduce the tendency of thespacer to move along, or to rotate about, certain axes.

In accordance with an embodiment, the spacer can be used in treatmentssuch as brachytherapy. For example, one or more of the slots, pockets,indentations, recesses, cavities or similar regions can receive aradiation source (shown by way of example as therapeutic load 120), suchas a radiation seed, rod, coil, powder or other form of radiationsource. Similarly, one or more of the slots, pockets, detents, recesses,cavities or similar regions can receive a pharmaceutical therapeuticload (shown by way of example as therapeutic load 122), such as amedicine such as a chemotherapy drug. In addition, therapy treatmentssuch as beads (or the contents thereof) that are drug eluding, and thatare available from Biocompatibles (UK) can also be used. Others of theslots, pockets, indentations, recesses, cavities or similar regions canbe left empty depending on the particular design and intended usage. Inthis manner, the spacer can be loaded with therapeutic loads, includingradiation sources and/or pharmaceutical therapeutic loads, so that whenthe spacer and its therapeutic loads are ultimately implanted or placedwithin the patient, along with other spacers and or radiation seeds, theradiation sources and/or pharmaceutical therapeutic loads will remainproperly spaced or constrained relative to one another in the spacer andthe spacers properly positioned between seeds, and hence with respect tothe area being treated.

In accordance with different embodiments, the encapsulating material 102can be made of a bio-absorbable and/or bio-adherent material, and/or canbe formed of a polymeric material or a plastic material and/ornon-bioabsorbable material. The fins, ribs or other physicalprotuberances or features that are used to reduce a tendency of thespacer to move or rotate can be of any number of different shapes andsizes, or combinations thereof, including for example square orrectangular knobs that cause the outer surface of the therapeutic spacerto resemble a knobby tire and/or a plurality of rows which are regularlyspaced about the spacer, e.g., with each row extending in a directionthat is 90 degrees from the adjacent rows. Alternatively, theprotrusions can protrude in a more random or irregular fashion. Theabove are just a few examples of the possible types of fins, ribs orother physical protuberances or features that can be used. Theprotrusions can have other dimensions while being within the scope ofthe present invention, additional examples of which are described incopending U.S. patent application Ser. No. 11/489,895 (published as U.S.Publication No. US2007/0021642).

In accordance with different embodiments, when the radiation seeds 220(FIG. 5B) or sources, the seeds can be of various types having lowenergy and low half-life such as Iodine seeds, known as I-125 seeds,including a welded titanium capsule containing iodine 125 adsorbed on asilver rod, or Palladium 103 seeds. Seeds may also have there isotopeadsorbed on ceramic beads, resin beads, silver beads, graphite pellets,porous ceramic rods, copper cores, etc. Seeds can have various differentshapes, such as, but not limited to, cylindrical with flat ends,cylindrical with rounded (e.g., bullet shaped) and spherical. One ofordinary skill in the art will appreciate from this description thatother types of radiation sources and seeds can be used, additionalexamples of which are similarly described in copending U.S. patentapplication Ser. Nos. 11/489,895 and 12/361,285 (U.S. Publication Nos.US2007/0021642 and US2009/0216063 respectively).

In accordance with different embodiments, the spacers can bemanufactured in various manners. For example, a molding process, such ascompression molding or injection molding can be used. A bio-absorbablepolymer or some other plastic material is introduced into the mold at atemperature that is above the melt point of the material such that thematerial flows within the mold cavity. The material is then allowed toset within the mold, e.g., by cooling the mold. After the material hasset, the mold is opened, and the finished spacer is retrieved.Therapeutic loads can then be inserted into the cavities, slots and/orpockets as required. Alternatively, solid materials or polymers can beplaced in the mold, with the heat from the mold melting the solidmaterials or polymers in order to form the spacers. Other methods ofmanufacturing can be used, additional examples of which are similarlydescribed in copending U.S. patent application Ser. Nos. 11/489,895 and12/361,285 (U.S. Publication Nos. US2007/0021642 and US2009/0216063respectively).

As part of the molding process, the pockets, slots, and otherindentations as well as the central bore and the end cavities can beformed with and defined by elements of the mold. Alternatively, thesepockets, slots and other indentations, central bore and end cavities canbe formed after the main body of the spacer is molded or otherwiseformed. For example, the pockets, slots and other indentation featuresmay be formed using a drilling, etching, or ablating process or byanother process that removes material from the spacer.

Further, as part of the manufacturing process, the pockets, slots,indentations, cavities, recesses or other similar regions as well as theend cavities and central bore can be filled with any of the therapeuticagents described therein and other therapeutic agents for treatment ofother ailments and diseases for use with the treatment of the prostateor other areas of the body of a human or other mammal or other animal.The therapeutic agents can be loaded into the pockets, slots and otherindentations as identified herein with various techniques. Suchtechniques include coating the spacer the agent and then removing excessagent, immersing the spacer into the agent, using an inkjet technique,mini-pipette, electro-spinning, auto-dispenser, or other method toinject the therapeutic agent into the pockets, slots or otherindentations as identified herein. Spraying techniques can be used toload the pockets, slots or other indentations with the therapeuticagents.

It is also to be understood that any of the therapeutic agents describedherein can also be placed in the spacer in such as way as to be evenlyor symmetrically distributed in the spacer or distributed in anasymmetrical manner. When distributed in an asymmetrical manner, any ofthe therapeutic agents can be distributed in order to treat one part ofthe body or organ of the body and not treat another part of the body orbody organ.

In accordance with different embodiments, the radiation sources can becoated with or contain a drug and/or hormone. Alternatively, a drugand/or hormone can be included in the encapsulating material itself, oras a separate therapeutic load. In accordance with an embodiment, theencapsulating material can include, but is not limited to, syntheticpolymers and copolymers of glycolide and lactide, polydioxanone and thelike. Such polymeric materials are more fully described in U.S. Pat.Nos. 3,565,869, 3,636,956, 4,052,988 and European Patent Publication No.0030822, and in copending U.S. patent application Ser. Nos. 11/489,895and 12/361,285 (U.S. Publication Nos. US2007/0021642 and US2009/0216063respectively), all of which are incorporated herein by reference.

When the spacer has been therapeutic loaded with the required radiationsource or pharmaceutical therapeutic loads, it must be implanted withinthe patient as part of the brachytherapy procedure. In accordance withan embodiment, an applicator such as a MICK™ applicator, or otherapplicator, can be used to implant the spacers at variable spacedlocations within a patient's body. Such an applicator is available fromMick Radio-Nuclear Instruments, Inc., of Mount Vernon, N.Y., andincludes a hollow needle that can be inserted into the patient's body,and a magazine for holding and dispensing spacers of the presentinvention (containing seeds, radiation sources, or other therapeuticloads) as well as, for example, brachytherapy seeds into the needle. Theneedle can be inserted into a patient in an area where a spacer is to beimplanted, and the spacer forced through the needle and into thepatient's body. Additional details describing the structure and the useof the MICK applicator are provided in copending U.S. patent applicationSer. Nos. 11/489,895 and 12/361,285 (U.S. Publication Nos.US2007/0021642 and US2009/0216063 respectively).

The above-described embodiments of the present invention relate tospacers that include one or more therapy sources. Other embodiments ofthe invention can be used together with elongated members known asstrands that include multiple therapy sources spaced from one another,for example as described in U.S. patent application Ser. No. 10/035,083,and incorporated herein by reference.

FIG. 2 shows an example of a spacer 130 in accordance with a particularembodiment. As shown in FIG. 2A, one example of a spacer can include anencapsulating material 132 formed as described above in the overallshape and appearance of a cylinder or elongated shape about alongitudinal axis, and including a center longitudinal bore 134, andfurther including a plurality of slot openings or ports 136, 137 on itssurface, and, in this example six, slots 138 distributed along thelongitudinal axis and extending from a first dorsal side to a seconddorsal side. In this embodiment the slots are provided on opposite sidesof the central bore.

In accordance with a particular example, the spacer can have a length of0.189 inch and a diameter of 0.038 inch. Each of the slots can be spaced0.042 inch apart, beginning 0.052 inch from a first distal end, and canhave dimensions of 0.020 inch wide 140, by 0.006 inch high, by 0.030inch deep 141.

As illustrated in the longitudinal cross-sectional view A-A shown inFIG. 2B, in accordance with this example, the slots 138 extend throughthe spacer from a first dorsal side to a second dorsal side of thespacer.

As illustrated in the transverse cross-sectional view B-B shown in FIG.2C, in accordance with this example, a center longitudinal bore 134 isincluded within the spacer. The linear exterior portions of the spacer142 can each have a width of 0.012 inch, set 90° apart from one another;while the spacer can have an external diameter of 0.038 inch; and thecenter bore 134 can have a diameter of 0.010 inch. In accordance withthis example, each slot is recessed from the surface of the spacer in aslightly recessed portion, so that the effective minor diameter 143 ofthe spacer at the slots is 0.034 inch, i.e. somewhat less than that ofthe spacer as a whole

As illustrated in the partial cross-sectional view of the end cavity 144shown in FIG. 2D, in accordance with this example, the end cavity can beincluded within the spacer. The center cavity can have a diameter 146 of0.020 inch, and a length 148 of 0.026 inch.

FIG. 3 shows an example of a spacer 160 in accordance with analternative embodiment. As shown in FIG. 3A, this example of a spacercan similarly include an encapsulating material 162 formed as describedabove in the overall shape and appearance of a cylinder or elongatedshape about a longitudinal axis. In accordance with this embodiment, thespacer does not include a center bore, but does include a plurality ofslot openings 166, 167 on its surface, and, in this example six slots168 distributed along the longitudinal axis and extending from a firstdorsal side to a second dorsal side. In accordance with this embodiment,the spacer further includes one or more fins, ribs or other physicalprotuberances or features 165 that improve the fixity of the spacer whenplaced in the body. These protuberances can be elongated and providedalong the longitudinal length of the spacer and on the outer surface ofthe spacer. Additionally the protuberances can be provides as rings orribs that are about perpendicular to the longitudinal axis of the spacerand extend from the surface of the spacer. Combinations of the aboveprotuberances can also be used to ensure the fixity of the spacer in thepatient.

In accordance with a particular example, the spacer can have a length of0.193 inch and a cylindrical diameter of 0.038 inch, with the outerdiameter including the fins being 0.041 inch. Each of the slots can bespaced 0.042 inch apart, beginning (measured at its edge) 0.044 inch or(measured at its center) 0.054 inch from a first distal end, and canhave dimensions of 0.020 inch wide 140, by 0.006 inch high, by 0.031inch deep 173.

As illustrated in the longitudinal cross-sectional view A-A shown inFIG. 3B, in accordance with this example, the slots 168 extend throughthe spacer from a first dorsal side to a second dorsal side of thespacer. In accordance with this example, each slot is positioned at itscenter 0.011 inch from the central axis, and is recessed from thesurface of the spacer in a slightly recessed portion, so that theeffective minor diameter 176 of the spacer at the slots is 0.034 inch,i.e. somewhat less than that of the spacer as a whole.

As illustrated in the transverse cross-sectional view B-B shown in FIG.3C, in accordance with this example, no center bore is included withinthe spacer. The linear exterior portion of the spacer 174 can have awidth of 0.010 inch, and its rib 165 can have a width of 0.004 inch.

FIG. 4 shows an example of a spacer 190 in accordance with analternative embodiment. As shown in FIG. 4A, this example of a spacercan include an encapsulating material 192 formed as described above inthe overall shape and appearance of a cylinder about a longitudinalaxis, not in this instance including a center bore or slots, but insteadincluding a plurality of, in this example twelve pockets 196, 197distributed along the longitudinal axis, and further including fins,ribs or other physical protuberances or features 195 such aslongitudinal fins that improve the fixity of the spacer when placed inthe body. In accordance with this example, the spacer can have a lengthof 0.193 inch, and each of the pockets can be spaced 0.042 inch apart,beginning (measured at its center) 0.052 inch from one end, and can havea width of 0.028 inch and a depth of 0.013 inch.

As illustrated in the longitudinal cross-sectional view A-A shown inFIG. 4B, in accordance with this example, the pockets 197 for receivingtherapeutic loads do not extend from a first dorsal side to a seconddorsal side of the spacer, but are instead close-ended or “pocket-like”.In this embodiment the each pocket is located in a quadrant of thespacer. Thus in this embodiment each quadrant that is locatedcircumferentially about the spacer has a pocket as show in FIG. 4B. Inaddition along the length of the spacer, each quadrant has three pocketsprovided therein, as shown in FIG. 4C.

As illustrated in the transverse cross-sectional view B-B shown in FIG.4C, in accordance with this example, no center bore is included withinthe spacer. The linear exterior portion of the spacer 202 can have awidth of 0.010 inch, and its rib 165 can have a width of 0.004 inch.Further, as seen in FIG. 4C, the pockets are distributedcircumferentially about the outer surface of the spacer such that thereis one pocket of 0.013×0.013 inch dimension in each quadrant about thecircumference of the spacer. Longitudinally along the length of thespacer there are three pockets in each quadrant. With this combinationof twelve pockets, drugs can be evenly distributed into all of thepockets or loaded in an asymmetrical way to give a asymmetricaldistribution of the therapeutic agent.

FIG. 5 shows an illustration of the therapeutic installation and use ofa spacer in accordance with an embodiment. As shown in FIG. 5A, a firstspacer 210 is inserted (see arrow) 212 into the patient's body via achannel 214, which can be created using a needle device such as the Mickapparatus. Depending on the particular design and intended usage, thespacer can include therapeutic loads, such as radiation sources and/orpharmaceutical therapeutic loads, indicated by way of example in FIG. 5as therapeutic loads 216 and 218 respectively. When the spacer and itstherapeutic loads are placed within the patient, the radiation sourcesand/or pharmaceutical therapeutic loads within that particular spacerremain properly spaced relative to one another.

As shown in FIG. 5B, a brachytherapy seed 220 can be inserted (seearrow) 222 into the patient's body via the channel, and abutted next toor adjacent the first spacer 210. When the seed and its therapeuticradiation loads are placed within the patient, the radiation sourcesand/or pharmaceutical therapeutic loads are properly spaced relative toone another, and also with respect to those of the first spacer 210.

As shown in FIGS. 5C and 5D, the process can be repeated with asubsequent seed 221 or subsequent spacer 224, so that the plurality ofradiation sources and/or pharmaceutical therapeutic loads are properlypositioned or spaced relative to one another over the plurality ofspacers, including spacing the first and second seeds a distance 226apart, corresponding to the length of the spacer.

The spacers can be provided to the doctors and hospitals in pre-loadedkits along with radiation seeds provide per treatment prescription plan.Alternatively, the spacers can be provided in kits and the doctor orhospital can load the spacers and/or seeds into inserting needles forthe medical procedure. Although the above illustrations show the use ofsimilar types of the spacer being used alone, it will be evident to oneof ordinary skill in the art that, in other use cases, different typesof spacer can be used together, as can different combinations of spacerand seeds be used, to deliver and position the most appropriatecombination of radiation sources and/or pharmaceutical therapeuticloads. In accordance with other embodiments different wells, slots,pocket and/or the spacer outer material itself can contain differenttherapeutic agents.

The foregoing description of the present invention has been provided forthe purposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise forms disclosed.Many modifications and variations will be apparent to the practitionerskilled in the art.

In particular, while various dimensions, numbers, and positions ofslots, pockets and other features have been provided above, inaccordance with other embodiments different dimensions, numbers, andpositions can be used.

The embodiments were chosen and described in order to best explain theprinciples of the invention and its practical application, therebyenabling others skilled in the art to understand the invention forvarious embodiments and with various modifications that are suited tothe particular use contemplated. It is intended that the scope of theinvention be defined by the following claims and their equivalence.

1. An apparatus for use in brachytherapy, radiotherapy, or other medicaltherapy, comprising: a spacer formed of an encapsulating material andwhich has a generally cylindrical and/or elongated shape about alongitudinal axis, and a spacer length associate therewith, and whereinthe spacer is adapted be implanted into a body of a patient; and whereinthe spacer includes a plurality of regions formed within the spacer,which plurality of regions are capable of receiving at least one ofradiation sources and/or pharmaceutical therapeutic loads, for use inbrachytherapy, radiotherapy, and other medical therapy.
 2. The apparatusof claim 1, wherein the spacer includes a center bore extending alongthe longitudinal axis through the spacer length, which center bore iscapable of receiving at least one of radiation sources and/orpharmaceutical therapeutic loads.
 3. The apparatus of claim 1, whereinthe spacer includes an end cavity in at least one end of the spacer,which at least one end cavity is capable of receiving at least one ofradiation sources and/or pharmaceutical therapeutic loads.
 4. Theapparatus of claim 1, wherein the spacer includes a plurality of slotsand/or pockets distributed along the spacer length and plurality ofslots and/or pockets have openings at dorsal sides of a surface of thespacer, which openings are capable of receiving at least one ofradiation sources and/or pharmaceutical therapeutic load.
 5. Theapparatus of claim 1, wherein the spacer has one or more fins, ribs orother physical protuberances or features on an exterior of the spacer,which fins, ribs or other physical protuberances or features improve thefixity of the spacer when placed within the body of the patient, as theone or more fins, ribs or other physical protuberances or features actto physically reduce the tendency of the spacer to move along, or torotate about, the longitudinal axis.
 6. The apparatus of claim 1,wherein the radiation sources and/or pharmaceutical therapeutic loadsare radioactive sources.
 7. The apparatus of claim 1, wherein theradiation sources and/or pharmaceutical therapeutic loads arepharmaceutical medicines.
 8. The apparatus of claim 1, wherein theradiation sources and/or pharmaceutical therapeutic loads areconstrained relative to one another by the spacer.
 9. The apparatus ofclaim 1, wherein a plurality of spacers can be implanted adjacent to atleast one of another spacer and a seed, to constrained the position ofspacers and seed relative to each other.
 10. A method of using a spacerfor use in brachytherapy, radiotherapy, or other medical therapy,comprising the steps of: implanting within a patient, a spacer formed ofan encapsulating material and which has a generally cylindrical and/orelongated shape about a longitudinal axis of said spacer, and a spacerlength associate therewith; and wherein the spacer includes a pluralityof regions formed within the spacer, which are capable of receiving atleast one of radiation sources and/or pharmaceutical therapeutic loads,for use in brachytherapy, radiotherapy, and other medical therapy. 11.The method of claim 10, wherein a plurality of spacers are implantedadjacent to at least one of another spacer and a seed, to constrainedthe spacers and seed relative to one another.
 12. A spacer for treatmentof a patient comprising: a longitudinal cylindrical body; a longitudinalbore through said body; a plurality of openings in the body and aboutthe longitudinal bore of said body; and therapeutic agent provided in atleast some of said openings.
 13. The spacer of claim 12 wherein saidopenings are one of slots, grooves, pockets, indentations, recesses, andcavities.
 14. The spacer of claim 12 wherein the openings are slots thatare about perpendicular to the longitudinal bore.
 15. The spacer ofclaim 12 wherein said plurality of openings are a plurality of slots,wherein some of the plurality of slots are about perpendicular to thelongitudinal bore and on one side of the longitudinal bore and some ofthe plurality of slots are about perpendicular to the longitudinal boreand on an opposite side of the longitudinal bore.
 16. The spacer ofclaim 12 wherein said openings are slots that communicate with a firstport that is in an outer surface of the spacer and communicate with asecond port in the outer surface of the spacer.
 17. The spacer of claim12 wherein said openings are pockets, which pockets communicate withonly one port in an outer surface of the spacer.
 18. The spacer of claim12 wherein said openings include pockets, and the spacer has quadrantsand with the pockets located in at lease some of the quadrants about acircumference of the spacer.
 19. The spacer of claim 12 wherein saidopenings include pockets and the spacer has quadrants and with thepockets located in the quadrants located circumferentially about thespacer and longitudinally along the spacer.
 20. The spacer of claim 12including protrusions extending from a surface of the spacer and locatedat least one of (1) longitudinally along the spacer and spaced from saidopenings, (2) circumferentially about said spacer and spaced from saidopenings, and (3) both longitudinally along the spacer and spaced fromsaid openings and circumferentially about said spacer and spaced fromsaid openings.
 21. The spacer of claim 19 wherein a cross-section of thespacer through the pockets is cross-shaped.
 22. The spacer of claim 12wherein said openings include a first plurality of pockets located in afirst quadrant of the spacer, a second plurality of pockets located in asecond quadrant of the spacer, a third plurality of pockets located in athird quadrant of the space, and a four plurality of pockets located ina four quadrant of the spacer.
 23. The spacer of claim 12 wherein saidopenings include a plurality of slots with each slot communicating witha first port in a surface of the spacer and with a second port in thesurface of the spacer, and wherein said slots are about parallel to eachother.
 24. The spacer of claim 12 wherein said openings include aplurality of slots with each slot communicating with a first port in asurface of the spacer and with a second port in the surface of thespacer, and wherein said slots are about parallel to each other andwherein some of the plurality of slots are on one side of thelongitudinal bore and some of the plurality of slots are on another sideof said longitudinal bore.
 25. An apparatus for use in brachytherapy,radiotherapy, or other medical therapy or treatment of a patientcomprising: a spacer formed of one or more materials, and which spacerhas a generally cylindrical and/or elongated shape and a longitudinalaxis, and a spacer length associate therewith, and wherein the spacer isadapted to can be implanted into a body of the patient; and wherein thespacer includes an outer layer of a hydrophilic material, and an innercore of a hydrophobic material.
 26. The apparatus of claim 25 whereinsaid hydrophilic material is bio-absorbable.
 27. The apparatus of claim25 wherein said hydrophobic material has an irregular outer surface, andthe hydrophilic material is bio-absorbable and wherein when thehydrophilic material is absorbed in tissue, the irregular outer surfaceof the hydrophobic material is adapted to hold the position of thespacer in the tissue.
 28. The apparatus of claim 25, further comprisinga plurality of openings in the spacer; and a therapeutic agent providedin the openings.
 29. The apparatus of claim 25, wherein the inner coreof the spacer is made of a length stable polymer, which said spacermaintains the spacer length while implanted in a patient, and wherein anouter porous surface of the spacer is adapted to absorb edema tomaintain a position in the needle trace in a patient for both the spacerand a seed.
 30. The apparatus of claim 25, wherein the inner core can bemade of biocompatible materials that are one of bioabsorbable ornon-bioabsorbable.
 31. The apparatus of claim 25, wherein the outerhydrophilic material can be a bio-absorbable material which is adaptedto become absorbed in the body and whereby said spacer become moresecurely located in the tissue of a patient.
 32. The apparatus of claim31, wherein as the hydrophilic material becomes absorbed, the remaininghydrophobic material is exposed with an irregular surface whichirregular surface is adapted to be retained in the tissue.
 33. Theapparatus of claim 31, wherein the core hydrophobic material has anirregular outer surface that is coated with the hydrophilic material ofthe outer layer that has a smoother outer surface offering lessresistance for initial injection into the tissue, and wherein as thehydrophilic material is absorbed into the tissue, the irregular outersurface of the inner core engages the tissue and holds the spacer inplace.
 34. The apparatus of claim 25, wherein, to use the spacer fordrug elution, the spacer is immersed into a liquid containing the drug,dehydrated and loaded into an applicator for implantation, and whereinonce implanted into the body of the patient, the spacer is rehydrated tocause the drug to elute.